Aquestive resubmits Anaphylm application after FDA rejection
Aquestive ($AQST) Therapeutics resubmitted its US new-drug application for Anaphylm, a sublingual film containing dibutepinephrine for severe allergic reactions, including anaphylaxis. The submission responds to the FDA’s earlier complete response letter and includes additional human-factors and pharmacokinetic information intended to address the agency’s concerns. Supporting work includes changes to the product’s packaging and evidence that users could open it more quickly. The company previous
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